A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

• Sponsor: Apollo Endosurgery, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00730327
• Collaborator: (none)
• Enrollment: 448
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: BioEnterics® Intragastric Balloon; Other: Behavioral modification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 448 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIB® Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.	Device: BioEnterics® Intragastric Balloon; Inflatable balloon inserted into the stomach.; Other Names: BIB® ; Other: Behavioral modification; Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Other: Control Control arm receives the Behavioral modification intervention only.	Other: Behavioral modification; Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise

Outcome Measures

Primary Outcome Measures

1. Mean Percent Excess Weight Loss (%EWL) [9 months]

   The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.

2. Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group [9 months]

   The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.

Secondary Outcome Measures

1. Percent of Participants With Comorbid Conditions [Baseline, Week 26, Week 39, Week 52]

   The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female).

2. Change in Quality of Life (SF-36) [Baseline, Week 39]

   The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.

3. Change in Quality of Life (IWQOL-Lite) [Baseline, Week 26, Week 39, Week 52]

   The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.

4. Change in Participant Depression (Beck Depression Inventory II) [Baseline, Week 26, Week 39, Week 52]

   Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a BMI ≥ 30 and ≤ 40;

• Be male or female, between 18 and 65 years of age, inclusive;

• Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;

• Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;

• Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks);

• Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing;

• Must be willing to take prescribed proton pump inhibitors (PPIs)and other medications as prescribed by the investigator;

• Be able to provide written informed consent and authorization for use and release of Health and Research Study Information;

• Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.

Exclusion Criteria:

• Any surgery of the foregut excluding uncomplicated cholecystectomy

• History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (>/= 2 cm);

• A patulous pyloric channel;

• History or symptoms of esophageal or GI motility disorders (not just those with <40%) as these patients are particularly susceptible to the development of esophagitis;

• History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE having been documented on a previously performed gastric scintigraphy study or another previously performed diagnostic study such as a UGI x-ray series;

• Current symptoms of delayed GE;

• A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);

• Anemia defined as a hemoglobin value for females of <11.3 g/dl and for males < 13.0 g/dl;

• History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;

• History or symptoms of inflammatory bowel disease, such as Crohn's disease or Ulcerative Colitis;

• History or symptoms of uncontrolled or unstable thyroid disease;

• Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects may participate in the study if, prior to randomization, they are treated with a pharmacological regimen designed to eradicate their H.p. and subsequently have a negative H.p. breath test indicating that the H.p. has been eradicated

• History or symptoms in the past 24 months of significant irritable bowel syndrome, peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding;

• Type I diabetes;

• Placement of previous intragastric balloon or similar device;

• Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastroduodenal mucosal irritants or to reduce GI motility, and/or an unwillingness to discontinue the use of these concomitant medications;

• Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study;

• Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia;

• Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential;

• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study;

• Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Apollo Endosurgery	Austin	Texas	United States	78746

Sponsors and Collaborators

• Apollo Endosurgery, Inc.

Investigators

• Study Director: Laura Eaton, RN, BSN, Apollo Endosurgery, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apollo Endosurgery, Inc.
• ClinicalTrials.gov Identifier: NCT00730327
• Other Study ID Numbers: IB-005
• First Posted: Aug 8, 2008
• Last Update Posted: Nov 6, 2015
• Last Verified: Oct 1, 2015

Study Results

Participant Flow

Recruitment Details	Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.
Pre-assignment Detail	448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Period Title: Overall Study
STARTED	125	130
Completed Week 26	125	99
COMPLETED	98	93
NOT COMPLETED	27	37

Baseline Characteristics

Arm/Group Title	BIB®	Control	Total
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Total of all reporting groups
Overall Participants	125	130	255
Age, Customized (participants) [Number]
18-19 years	1 0.8%	0 0%	1 0.4%
20-29 years	21 16.8%	18 13.8%	39 15.3%
30-39 years	49 39.2%	37 28.5%	86 33.7%
40-49 years	31 24.8%	54 41.5%	85 33.3%
50-59 years	22 17.6%	16 12.3%	38 14.9%
60 years & over	1 0.8%	5 3.8%	6 2.4%
Sex: Female, Male (Count of Participants)
Female	112 89.6%	117 90%	229 89.8%
Male	13 10.4%	13 10%	26 10.2%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	101 80.8%	106 81.5%	207 81.2%
Hispanic	9 7.2%	7 5.4%	16 6.3%
Black (not of Hispanic origin)	14 11.2%	15 11.5%	29 11.4%
Asian	0 0%	0 0%	0 0%
Other	1 0.8%	2 1.5%	3 1.2%
BMI (participants) [Number]
BMI <30	2 1.6%	1 0.8%	3 1.2%
BMI ≥30 and <35	63 50.4%	57 43.8%	120 47.1%
BMI ≥35 and ≤40	56 44.8%	70 53.8%	126 49.4%
BMI >40	4 3.2%	2 1.5%	6 2.4%
Number of Years Obese (participants) [Number]
< 5 years obese	20 16%	22 16.9%	42 16.5%
5-9 years obese	35 28%	26 20%	61 23.9%
10-19 years obese	38 30.4%	51 39.2%	89 34.9%
20-29 years obese	18 14.4%	19 14.6%	37 14.5%
30-39 years obese	10 8%	6 4.6%	16 6.3%
40-49 years obese	1 0.8%	4 3.1%	5 2%
50 years obese & over	0 0%	0 0%	0 0%
Unknown	3 2.4%	2 1.5%	5 2%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Excess Weight Loss (%EWL)
Description	The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	91	95
Mean (Standard Deviation) [percentage of EWL]	26.52 (20.70)	9.67 (15.11)

2. Primary Outcome

Title	Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group
Description	The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).

Arm/Group Title	BIB®
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	91
15% EWL over the control group mean	45.60 36.5%
25% EWL over the control group mean	32.8 26.2%

3. Secondary Outcome

Title	Percent of Participants With Comorbid Conditions
Description	The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female).
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	125	130
Diabetes-Baseline (BIB n=124, Control n=130)	7.3 5.8%	6.2 4.8%
Diabetes-Week 26 (BIB n=100, Control n=94)	3.0 2.4%	4.3 3.3%
Diabetes-Week 39 (BIB n=102, Control n=94)	4.9 3.9%	3.2 2.5%
Diabetes-Week 52 (BIB n=95, Control n=94)	3.2 2.6%	5.3 4.1%
Hypertension-Baseline (BIB n=125, Control n=130)	26.4 21.1%	28.5 21.9%
Hypertension-Week 26 (BIB n=124, Control n=91)	17.7 14.2%	19.8 15.2%
Hypertension-Week 39 (BIB n=91, Control n=95)	15.4 12.3%	21.1 16.2%
Hypertension-Week 52 (BIB n=98, Control n=92)	11.2 9%	22.8 17.5%
Dyslipidemia-Baseline (BIB n=125, Control n=130)	39.2 31.4%	30.0 23.1%
Dyslipidemia-Week 26 (BIB n=102, Control n=94)	31.4 25.1%	27.7 21.3%
Dyslipidemia-Week 39 (BIB n=102, Control n=95)	28.4 22.7%	28.4 21.8%
Dyslipidemia-Week 52 (BIB n=96, Control n=94)	30.2 24.2%	26.6 20.5%

4. Secondary Outcome

Title	Change in Quality of Life (SF-36)
Description	The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.
Time Frame	Baseline, Week 39

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	123	130
Physical Func-Baseline (BIB n=122, Control n=130)	71.4 (22.09)	73.7 (21.14)
Physical Func-Week 39 (BIB n=98, Control n=92)	90.0 (14.26)	85.4 (15.5)
Role Physical-Baseline (BIB n=123, Control n=130)	78.5 (21.59)	80.3 (23.07)
Role Physical-Week 39 (BIB n=98, Control n=93)	93.0 (13.56)	85.6 (20.89)
Bodily Pain-Baseline (BIB n=123, Control n=130)	72.8 (21.88)	75.4 (22.34)
Bodily Pain-Week 39 (BIB n=99, Control n=93)	84.9 (18.84)	76.2 (23.91)
General Health-Baseline (BIB n=123, Control n=128)	61.9 (20.22)	63.4 (20.11)
General Health-Week 39 (BIB n=99, Control n=93)	79.1 (16.53)	68.6 (20.67)
Vitality-Baseline (BIB n=123, Control n=130)	52.7 (18.19)	53.0 (19.11)
Vitality-Week 39 (BIB n=99, Control n=93)	67.6 (17.74)	58.3 (21.08)
Social Func-Baseline (BIB n=123, Control n=130)	80.5 (21.89)	80.8 (23.30)
Social Func-Week 39 (BIB n=99, Control n=93)	92.6 (13.35)	83.3 (22.14)
Role Emotional-Baseline (BIB n=123, Control n=130)	84.0 (22.65)	84.6 (20.81)
Role Emotional-Week 39 (BIB n=98, Control n=93)	92.2 (15.55)	86.8 (19.75)
Mental Health-Baseline (BIB n=123, Control n=130)	74.0 (17.91)	73.7 (16.60)
Mental Health-Week 39 (BIB n=99, Control n=93)	80.1 (15.82)	72.5 (18.09)

5. Secondary Outcome

Title	Change in Quality of Life (IWQOL-Lite)
Description	The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	121	127
Baseline (BIB n=121, Control n=127)	68.40 (18.733)	68.55 (17.356)
Week 26 (BIB n=103, Control n=94)	84.64 (12.888)	76.67 (16.472)
Week 39 (BIB n=99, Control n=93)	85.78 (14.411)	78.58 (16.833)
Week 52 (BIB n=97, Control n=94)	85.79 (15.424)	79.85 (16.189)

6. Secondary Outcome

Title	Change in Participant Depression (Beck Depression Inventory II)
Description	Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	124	130
Baseline (BIB n=124, Control n=130)	7.7 (7.92)	8.4 (7.79)
Week 26 (BIB n=104, Control n=95)	3.7 (4.83)	7.0 (8.30)
Week 39 (BIB n=99, Control n=93)	3.6 (5.12)	6.3 (6.68)
Week 52 (BIB n=97, Control n=95)	3.9 (6.42)	5.7 (7.30)

7. Post-Hoc Outcome

Title	Change in BMI
Description	Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	125	130
Baseline (BIB n=125, Control n=130)	35.20 (3.165)	35.43 (2.650)
Week 26 (BIB n=117, Control n=91)	31.43 (3.762)	33.61 (3.253)
Week 39 (BIB n=91, Control n=95)	31.85 (4.035)	33.83 (3.300)
Week 52 (BIB n=98, Control n=92)	32.50 (4.177)	33.96 (3.517)

8. Post-Hoc Outcome

Title	Percent EWL (Using BMI=25 kg/m²)
Description	Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25.
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	125	130
Week 26 (BIB n=117, Control n=91)	38.4 (27.61)	12.1 (18.58)
Week 39 (BIB n=91, Control n=95)	34.6 (28.4)	12.3 (19.33)
Week 52 (BIB n=98, Control n=92)	29.0 (30.70)	11.1 (20.67)

9. Post-Hoc Outcome

Title	Percent Total Body Weight Loss (%TBWL)
Description	Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).
Time Frame	Baseline, Week 26, Week 39, Week 52

Outcome Measure Data

Analysis Population Description

Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).

Arm/Group Title	BIB®	Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Measure Participants	125	130
Week 26 (BIB n=117, Control n=91)	10.2	3.3
Week 39 (BIB n=91, Control n=93)5	9.1	3.4
Week 52 (BIB n=98, Control n=92)	7.6	3.1

Adverse Events

Time Frame	Adverse event (AE) data was collected over a period of 12 months.
Adverse Event Reporting Description	AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Arm/Group Title	BIB®		Control
Arm/Group Description	Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise		Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
All Cause Mortality
	BIB®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BIB®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/125 (15.2%)		8/130 (6.2%)
Blood and lymphatic system disorders
Chronic myelogenous leukemia	1/125 (0.8%)	1	0/130 (0%)	0
Cardiac disorders
Syncope	1/125 (0.8%)	1	0/130 (0%)	0
Endocrine disorders
Hyperparathyroidism	1/125 (0.8%)	1	0/130 (0%)	0
Hemithyroidectomy	0/125 (0%)	0	1/130 (0.8%)	1
Gastrointestinal disorders
Irritable bowel syndrome	1/125 (0.8%)	1	0/130 (0%)	0
Ventral hernia	1/125 (0.8%)	1	0/130 (0%)	0
Diverticulitis	1/125 (0.8%)	1	0/130 (0%)	0
Gastric outlet obstruction	1/125 (0.8%)	1	0/130 (0%)	0
General disorders
Defective device	1/125 (0.8%)	1	0/130 (0%)	0
Hepatobiliary disorders
Choledocholithiasis	1/125 (0.8%)	1	0/130 (0%)	0
Cholelithiasis	0/125 (0%)	0	1/130 (0.8%)	1
Sphincter of Oddi dysfunction	0/125 (0%)	0	1/130 (0.8%)	1
Infections and infestations
Giardia lamblia infection	1/125 (0.8%)	1	0/130 (0%)	0
Viral gastroparesis	1/125 (0.8%)	1	0/130 (0%)	0
Injury, poisoning and procedural complications
Motor vehicle accident with nasal fracture	0/125 (0%)	0	1/130 (0.8%)	1
Investigations
Device Intolerance	8/125 (6.4%)	8	0/130 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/125 (0.8%)	1	0/130 (0%)	0
Musculoskeletal and connective tissue disorders
Osteoarthritis of the hip	1/125 (0.8%)	1	0/130 (0%)	0
Herniated lumbar disc	0/125 (0%)	0	1/130 (0.8%)	1
Renal and urinary disorders
Renal cell carcinoma with nephrectomy	0/125 (0%)	0	1/130 (0.8%)	1
Reproductive system and breast disorders
Dysmenorrhea	1/125 (0.8%)	1	0/130 (0%)	0
Breast abscess	1/125 (0.8%)	1	0/130 (0%)	0
Ovarian cyst	1/125 (0.8%)	1	1/130 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Laryngospasm	1/125 (0.8%)	1	0/130 (0%)	0
Vascular disorders
Bilateral vertebral artery hypoplasia	0/125 (0%)	0	1/130 (0.8%)	1
Other (Not Including Serious) Adverse Events
	BIB®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	124/125 (99.2%)		92/130 (70.8%)
Gastrointestinal disorders
Abdominal Distension	23/125 (18.4%)	23	4/130 (3.1%)	4
Abdominal Pain	81/125 (64.8%)	81	5/130 (3.8%)	5
Abdominal Pain Upper	23/125 (18.4%)	23	0/130 (0%)	0
Constipation	31/125 (24.8%)	31	6/130 (4.6%)	6
Diarrhea	25/125 (20%)	25	9/130 (6.9%)	9
Dyspepsia	30/125 (24%)	30	0/130 (0%)	0
Eructation	29/125 (23.2%)	29	0/130 (0%)	0
Flatulence	14/125 (11.2%)	14	0/130 (0%)	0
Gastroesophageal Reflux Disease (GERD)	38/125 (30.4%)	38	6/130 (4.6%)	6
Impaired Gastric Emptying	16/125 (12.8%)	16	5/130 (3.8%)	5
Nausea	112/125 (89.6%)	112	7/130 (5.4%)	7
Vomiting	97/125 (77.6%)	97	7/130 (5.4%)	7
General disorders
Asthenia	10/125 (8%)	10	0/130 (0%)	0
Fatigue	9/125 (7.2%)	9	0/130 (0%)	0
Infections and infestations
Bronchitis	9/125 (7.2%)	9	11/130 (8.5%)	11
Ear Infection	5/125 (4%)	5	4/130 (3.1%)	4
Nasopharyngitis	6/125 (4.8%)	6	7/130 (5.4%)	7
Pharyngitis streptococcal	4/125 (3.2%)	4	6/130 (4.6%)	6
Sinusitis	11/125 (8.8%)	11	19/130 (14.6%)	19
Upper respiratory tract infection	10/125 (8%)	10	13/130 (10%)	13
Viral infection	6/125 (4.8%)	6	0/130 (0%)	0
Injury, poisoning and procedural complications
Medical device complication	8/125 (6.4%)	8	0/130 (0%)	0
Post procedural pain	9/125 (7.2%)	9	0/130 (0%)	0
Investigations
Blood cholesterol increased	6/125 (4.8%)	6	0/130 (0%)	0
Blood thyroid stimulating hormone decreased	0/125 (0%)	0	4/130 (3.1%)	4
Vitamin B1 decreased	0/125 (0%)	0	5/130 (3.8%)	5
Metabolism and nutrition disorders
Dehydration	17/125 (13.6%)	17	0/130 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	6/125 (4.8%)	6	9/130 (6.9%)	9
Pain in extremity	6/125 (4.8%)	6	0/130 (0%)	0
Back pain	0/125 (0%)	0	10/130 (7.7%)	10
Pain in extremity	0/125 (0%)	0	4/130 (3.1%)	4
Nervous system disorders
Headache	11/125 (8.8%)	11	7/130 (5.4%)	7
Migraine	0/125 (0%)	0	4/130 (3.1%)	4
Psychiatric disorders
Anxiety	5/125 (4%)	5	0/130 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	6/125 (4.8%)	6	0/130 (0%)	0
Nasal congestion	5/125 (4%)	5	0/130 (0%)	0
Skin and subcutaneous tissue disorders
Rash	7/125 (5.6%)	7	0/130 (0%)	0
Vascular disorders
Hypertension	4/125 (3.2%)	4	6/130 (4.6%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.